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A Comparison of ISIS 2922 Used Immediately or Later in Patients with Cytomegalovirus (CMV) of the Eyes Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about A Comparison of ISIS 2922 Used Immediately or Later in Patients with Cytomegalovirus (CMV) of the Eyes conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. A Comparison of ISIS 2922 Used Immediately or Later in Patients with Cytomegalovirus (CMV) of the Eyes Clinical research trials and A Comparison of ISIS 2922 Used Immediately or Later in Patients with Cytomegalovirus (CMV) of the Eyes medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as A Comparison of ISIS 2922 Used Immediately or Later in Patients with Cytomegalovirus (CMV) of the Eyes. A Comparison of ISIS 2922 Used Immediately or Later in Patients with Cytomegalovirus (CMV) of the Eyes Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a A Comparison of ISIS 2922 Used Immediately or Later in Patients with Cytomegalovirus (CMV) of the Eyes clinical trial. Subjects often receive the most expert healthcare possible for their A Comparison of ISIS 2922 Used Immediately or Later in Patients with Cytomegalovirus (CMV) of the Eyes condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Comparison of ISIS 2922 Used Immediately or Later in Patients with Cytomegalovirus (CMV) of the Eyes  A Comparison of ISIS 2922 Used Immediately or Later in Patients with Cytomegalovirus (CMV) of the Eyes
A Comparison of ISIS 2922 Used Immediately or Later in Patients with Cytomegalovirus (CMV) of the Eyes
For Condition: Cytomegalovirus Retinitis,HIV Infections
Status: Completed
Sponsor(s): Isis Pharmaceuticals ,
Synopsis: To determine a clinically safe and effective dose of intravitreally injected ISIS 2922 and to compare the safety and efficacy of immediate versus delayed treatment in AIDS patients with previously untreated, peripheral cytomegalovirus ( CMV ) retinitis.
Details: In Stage 1 (dose escalation), patients receive either 75 or 150 mcg intravitreal ISIS 2922. In Stage 2 (randomization), patients are enrolled in either the immediate treatment group or delayed treatment group. Immediate treatment consists of intravitreal ISIS 2922 every 7 days for 3 injections (Induction) then every 14 days for 18 weeks (Maintenance). Patients in the delayed treatment group receive no immediate anti-CMV treatment but are monitored weekly for disease progression. If disease progresses, patient receives ISIS 2922 on an identical dosage regimen as those on immediate treatment. Patients may continue ISIS 2922 on a biweekly extended maintenance schedule if dose is considered safe and the CMV retinitis is clinically controlled. Per 2/8/96 amendment, patients are now in Stage 2 at 150 mcg.
Eligibility:
Study Type: Interventional, Treatment, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients must have: - AIDS. - Clinical diagnosis of previously untreated peripheral CMV retinitis in one eye. - Leading edge of a CMV retinitis lesion is at least 750 microns from zone one. NOTE: - Patients with CMV retinitis in zone three only may be eligible if the lesions can be reliably photographed to follow progression. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions in the eye to be treated are excluded: - External ocular infections. - Other herpetic infections of the retina, toxoplasma retinochoroiditis, or other disease of the fundus. - Ocular conditions that will obstruct visualization of the posterior ocular structures. - Retinal detachment. - Silicone oil in eye. Patients with the following other symptoms or conditions are excluded: - Known or suspected allergy to phosphorothioate oligonucleotides. - Syphilis. - Pseudoretinitis pigmentosa. Concurrent Medication: Excluded: - Current treatment for extra-ocular CMV infection. - Ganciclovir. - Foscarnet. - Mellaril. - Stelazine. - Thorazine. - Clofazimine. - Ethambutol/fluconazole combination. - Investigational medications for CMV retinitis. Concurrent Treatment: Excluded: - Investigational procedures for CMV retinitis. Patients with the following prior conditions are excluded: - History of surgery to correct retinal detachment in the eye to be treated. - History of syphilis. Prior Medication: Excluded: - Prior anti-CMV retinitis treatment in either eye. - Anti-CMV therapy for extra-ocular infection within the past 2 days.
Total Enrollment: 60
Location and Contact Information:
Vitreo - Retinal Consultants
New York City, New York, 10028
United States
Retina - Vitreous Associates Med Group
Los Angeles, California, 90017
United States
Univ of Illinois
Chicago, Illinois, 60612
United States
Virginia Eye Consultants
Norfolk, Virginia, 23507
United States
Dr Julio Perez
Ft. Lauderdale, Florida, 33060
United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
United States
Charlotte Eye Ear Nose & Throat Association
Charlotte, North Carolina, 28204
United States
Indiana Univ Med Ctr
Indianapolis, Indiana, 46202
United States
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, 752359057
United States
Santa Clara Valley Med Ctr
San Jose, California, 95128
United States
Novum Inc
Seattle, Washington, 98104
United States
Community Eye Med Group
Pasadena, California, 911052536
United States
Georgia Retina
Atlanta, Georgia, 30327
United States
Additional Information:
Study ID Numbers: 251A; ISIS 2922-CS2
Study Start Date:
Record last reviewed: July 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002355
Other Cytomegalovirus Retinitis Studies:
1. The Safety and Effectiveness of Cidofovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients with AIDS
2. A Randomized Study Comparing the Safety and Efficacy of Two Regimens of Oral Ganciclovir to Intravenous Ganciclovir Maintenance Therapy for Cytomegalovirus Retinitis in People with AIDS Who Have Received Prior Ganciclovir Therapy
3. An Open Label Evaluation of the Safety and Pharmacokinetics of Ganciclovir in Children
4. A Phase II Dose-Ranging, Open-Labelled Trial of Foscarnet Salvage Therapy for AIDS Patients With Sight-Threatening CMV Retinitis Who Cannot Be Treated With Ganciclovir Due To Myelosuppression or Treatment Failure
5. Suppression of Cytomegalovirus Retinitis Utilizing High Dose Intravenous Acyclovir and Oral Zidovudine in Patients With AIDS
Related Studies:
Other Cytomegalovirus Retinitis Clinical Trials
Other Florida Clinical Trials
Other Ft. Lauderdale Clinical Trials
A Comparison of ISIS 2922 Used Immediately or Later in Patients with Cytomegalovirus (CMV) of the Eyes
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